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Disseminated intravascular coagulation (DIC): Since disseminated intravascular coagulation (DIC) (0.4%) may occur, the patient's condition should be monitored closely. If any abnormal findings are observed on blood tests including those for platelet count, serum FDP level and plasma fibrinogen level, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Severe hepatic disorder such as fulminant hepatitis: Since severe hepatic disorders such as fulminant hepatitis (including reactivation of hepatitis B virus) (incidence unknown) may occur, patient's condition should be monitored closely by periodic hepatic function tests. If any abnormal findings are observed, appropriate measures should be taken, such as discontinuing administration of TS-ONE. (See Warnings.)
Dehydration: Since severe diarrhea may occur, and may lead to dehydration (incidence unknown), the patient's condition should be monitored closely. If any such symptoms are observed, TS-ONE administration should be discontinued, and appropriate measures should be taken, such as fluid replacement.
Severe enteritis (0.5%): Since hemorrhagic enterocolitis, ischaemic enterocolitis and necrotising enterocolitis may occur, the patient's condition should be monitored closely. If severe symptoms such as abdominal pain and diarrhea occur, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Interstitial pneumonia: Since interstitial pneumonia (0.3%) (early symptoms: cough, shortness of breath, dyspnea and fever) may occur, the patient's condition should be monitored closely. If any abnormal findings are observed, TS-ONE administration should be discontinued, and appropriate measures should be taken, such as chest X-ray examination and treatment with corticosteroids.
Myocardial infarction, angina pectoris, arrhythmia, cardiac failure: Since myocardial infarction, angina pectoris, arrhythmia (including ventricular tachycardia) and cardiac failure (the incidences of these adverse reactions are unknown) may occur, the patient's condition should be monitored closely. If chest pain, syncope, palpitation, abnormal ECG or breathlessness are observed, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Severe stomatitis, gastrointestinal ulcer, gastrointestinal hemorrhage and gastrointestinal perforation: Since severe stomatitis (incidence unknown), gastrointestinal ulcer (0.5%), gastrointestinal hemorrhage (0.3%) and gastrointestinal perforation (incidence unknown) may occur, the patient's condition should be monitored closely. If any abnormal findings are observed, TS-ONE administration should be discontinued and appropriate measures should be taken, such as examination by abdominal X-ray.
Acute kidney injury and nephrotic syndrome: Since severe renal disorder such as acute kidney injury and nephrotic syndrome (incidence unknown) may occur, the patient's condition should be monitored closely. If any abnormal findings are observed, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Toxic epidermal necrolysis (TEN) and muco-cutaneo-ocular syndrome (Stevens-Johnson syndrome): Since toxic epidermal necrolysis and muco-cutaneo-ocular syndrome (incidence unknown) may occur, the patient's condition should be monitored closely. If any abnormal findings are observed, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Psychoneurologic disorders including leukoencephalopathy or other symptoms: Since leukoencephalopathy (major symptoms include consciousness disturbance, cerebellar ataxia, and dementia-like symptoms), consciousness disturbance, disorientation, somnolence, hypomnesia, extrapyramidal symptoms, speech disorder, quadriplegia, gait disturbance, urinary incontinence, or sensory disturbance (the incidences of these adverse reactions are unknown) may occur, the patient's condition should be monitored closely, and if any such symptoms are observed, TS-ONE administration should be discontinued.
Acute pancreatitis: Since acute pancreatitis (incidence unknown) may occur, the patient's condition should be monitored closely. If abdominal pain or increased serum amylase were observed, TS-ONE administration should be discontinued, and appropriate measures should be taken.
Rhabdomyolysis: Since rhabdomyolysis (incidence unknown) marked by muscle pain, feeling of weakness, increased CK (CPK) and increased myoglobin in the blood or urine may occur, TS-ONE administration should be discontinued, and appropriate measures should be taken. Also, care should be taken to avoid appearance of acute kidney injury due to rhabdomyolysis.
Anosmia: Since dysosmia (0.1%) may occur, and anosmia (incidence unknown) may develop, the patient's condition should be monitored closely. If any abnormal findings are observed, appropriate measures should be taken, such as discontinuing administration of TS-ONE.
Lacrimal duct obstruction: Lacrimal duct obstruction (incidence unknown) may occur, and some patients have been reported to undergo surgical procedures. If any symptoms such as lacrimation are observed, appropriate measures should be taken, such as ophthalmic examination.
Clinically significant adverse reactions (similar drugs): Since the following adverse reactions have been reported to be caused by tegafur, if any abnormal findings are observed, appropriate measures should be taken, such as discontinuing administration of TS-ONE.
Hepatic cirrhosis: Prolonged prothrombin time, decreased albumin and decreased cholinesterase.
Other adverse reactions: Since the following adverse reactions may occur, if any abnormal findings are observed, appropriate measures should be taken, such as dose reduction or discontinuing administration of TS-ONE. If hypersensitivity is observed, TS-ONE administration should be discontinued, and appropriate measures should be taken. Also, in case of previously-treated breast cancer, the incidence of hand-foot syndrome was high (21.8%). In patients who were administered TS-ONE in the post-marketing clinical study for unresectable or recurrent gastric cancer, the incidence of lacrimation was high (16.0%). (See Table 10.)
Click on icon to see table/diagram/imageOther adverse reactions (similar drugs): Since the following adverse reactions have been reported to be caused by tegafur, if any abnormal findings are observed, appropriate measures should be taken, such as dose reduction or discontinuing administration of TS-ONE.
Fatty liver, difficulty in swallowing, tinnitus, excitement, increased serum uric acid, gynecomastia.
Adverse reactions from other clinical studies in Japan (Reference from Japan Package Insert): Monotherapy: Of 578 patients evaluable for adverse reactions in clinical studies with TS-ONE monotherapy excluding the following patients with previously-treated breast cancer, pancreatic cancer, and biliary tract cancer, the incidence of adverse reactions was 87.2% (504 patients). Also, in patients with inoperable or recurrent breast cancer previously treated with taxane-group anticancer drugs, pancreatic cancer, and biliary tract cancer, the incidence of adverse reactions was high (96.4%, 98.3% and 94.9%, respectively) compared to patients with other cancer types. Pancreatic cancer patients showed also high incidences of severe adverse reactions, in particular gastrointestinal disorders such as anorexia, nausea, vomiting, and diarrhea. The following adverse reactions appear to be important clinically. (See Table 11.)
The results of analysis regarding time of onset of the adverse reactions and the period of recovery are described in Clinical Studies (see Pharmacology: Clinical Studies under Actions).
Click on icon to see table/diagram/imageCombination therapy: Of 55 patients evaluable for adverse reactions in a late phase II clinical study with combination therapy (a 21-day consecutive oral administration of TS-ONE and an administration of cisplatin at 60 mg/m2 on day 8) for non-small cell lung cancer, some kinds of adverse reactions occurred among all 55 patients. The following adverse reactions appear to be important clinically. (See Table 12.)
Click on icon to see table/diagram/imageIncidence rates of interstitial pneumonia and other pulmonary disorders in a drug use investigation in patients with non-small cell lung cancer: A post-marketing drug use investigation in patients with non-small cell lung cancer reported incidence rates of 0.7% (11/1669) for interstitial pneumonia and 0.7% (12/1669) for other pulmonary disorders including radiation pneumonitis, dyspnea, and respiratory failure.
Studies in Europe/United States of America (EU/USA) of patients treated with TS-ONE in combination with cisplatin (Reference from EU SmPC): The following headings are used to rank the adverse reactions by frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data). The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with TS-ONE in combination with cisplatin in clinical trials. The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with TS-ONE-based therapy. Each term is presented in its most common category only and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions reported by decreasing seriousness in each frequency grouping: See Tables 13a and 13b.
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
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